D.C. Mun. Regs. tit. 22, r. 22-B10301
The words "intended uses" or words of similar import in §§ 10302, 10312, and 10314 of this chapter refer to the objective intent of the persons legally responsible for the labeling of devices. The intent is determined by such persons' expressions or may be shown by the circumstances surrounding the distribution of the medical device.
The objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such persons or their representatives. It may be shown by the circumstances that the article is, with the knowledge of such persons or their representatives, offered and used for a purpose for which it is neither labeled nor advertised. The intended uses of a medical device may change after it has been introduced into interstate commerce by its manufacturer.
If, for example, a packer, distributor, or seller intends a medical device for different uses than those intended by the person from whom he received the devices, the packer, distributor, or seller is required to supply adequate labeling in accordance with the new intended uses.
If a manufacturer knows, or has knowledge of facts that would give him or her notice that a device introduced into interstate commerce by him or her is to be used for conditions, purposes, or uses other than the ones for which he offers it, he is required to provide adequate labeling for such a device which accords with the other uses to which the medical device is to be put.
D.C. Mun. Regs. tit. 22, r. 22-B10301